510(k) · Cleared

Recalled · Class II · 2013

Modification to Endius Atavi System

K061345510(k) SpecialCleared Jun 6, 200622-day reviewClass II21 CFR 888.1100Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cleared on Jun 6, 2006 as substantially equivalent to K991794 (Endius, Inc., 1999) and 5 other predicates after a 22-day review. Its family tree reaches back 3 generations to 1999. 17 later devices descend from it. It has been recalled once.

Decided: Jun 6, 2006
Review: 22 days
Class: Class II
Product code: HRX
Recalls: 1
Predicates: 6

Its longest line of descent runs back 3 generations to K991794 (1999). 7 ancestors in all. 17 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK991794 Endoscopic Spinal Access SystemEndius, Inc. · 1999
2 generations backK021748 Endius Atavi SystemEndius, Inc. · 2002
1 generation backK053267 Endius Atavi SystemEndius, Inc. · 2006 · Recalled
This deviceK061345 Modification to Endius Atavi SystemEndius, Inc. · 2006
Descendant · cites it directly · 16 of its ownK081051 Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc. · 2008
Descendant · 2 generations on · 7 of its ownK102733 Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology…Vision-Sciences, Inc. · 2011
Descendant · 2 generations on · 7 of its ownK090278 Enspire Debrider SystemSpine View, Inc. · 2009
Descendant · 3 generations on · 6 of its ownK110992 Enspire Debrider SystemSpine View, Inc. · 2011
Descendant · 4 generations on · 2 of its ownK120553 ESPINNlt Spine, Ltd. · 2012

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2008high 6 (2012) · low 0 (2010)2026

Most influential descendants

Showing 5 of 17 · See all

K081051Spinevu Endoscopic Spine System (Sess), Spinevu MiniscopeSpine View, Inc. · 2008 · cites it directly16descendants
K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences…Vision-Sciences, Inc. · 2011 · 2 generations on7descendants
K090278Enspire Debrider SystemSpine View, Inc. · 2009 · 2 generations on7descendants
K110992Enspire Debrider SystemSpine View, Inc. · 2011 · 3 generations on6descendants
K120553ESPINNlt Spine, Ltd. · 2012 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K991794	Endoscopic Spinal Access System	Endius, Inc.	1999	—
−2	K021748	Endius Atavi System	Endius, Inc.	2002	—
−1	K053267	Endius Atavi System	Endius, Inc.	2006	1
0 (this device)	K061345	Modification to Endius Atavi System	Endius, Inc.	2006	—
+1	K081051	Spinevu Endoscopic Spine System (Sess), Spinevu Miniscope	Spine View, Inc.	2008	—
+2	K102733	Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology…	Vision-Sciences, Inc.	2011	—
+2	K090278	Enspire Debrider System	Spine View, Inc.	2009	—
+3	K110992	Enspire Debrider System	Spine View, Inc.	2011	—
+4	K120553	ESPIN	Nlt Spine, Ltd.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	3	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2011	2	0
2012	6	0
2013	2	0
2015	3	0
2017	1	0
2018	1	0

FIG. 1 — Lineage of K061345, 1999–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HRX device

#1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K991794	Endoscopic Spinal Access System Summary page 2 …us Atavi System May 12, 2006 5.5 Predicate Devices Device Name(s): Endius Atavi System 510(k) Number(s): K991794, K994425, K002437, K021748, K022199, K053267 5.6 Device Description The Endius Atavi System includes instruments used to access…	Endius, Inc.	1999	—
*	K994425	Modification to Endoscopic Spinal Access System Summary page 2 …System May 12, 2006 5.5 Predicate Devices Device Name(s): Endius Atavi System 510(k) Number(s): K991794, K994425, K002437, K021748, K022199, K053267 5.6 Device Description The Endius Atavi System includes instruments used to access the spin…	Endius, Inc.	2000	—
*	K002437	Endius Endoscopic Access System Summary page 2 …May 12, 2006 5.5 Predicate Devices Device Name(s): Endius Atavi System 510(k) Number(s): K991794, K994425, K002437, K021748, K022199, K053267 5.6 Device Description The Endius Atavi System includes instruments used to access the spine by dila…	Endius, Inc.	2000	—
*	K021748	Endius Atavi System Summary page 2 …May 12, 2006 5.5 Predicate Devices Device Name(s): Endius Atavi System 510(k) Number(s): K991794, K994425, K002437, K021748, K022199, K053267 5.6 Device Description The Endius Atavi System includes instruments used to access the spine by dilation of t…	Endius, Inc.	2002	—
*	K022199	Endius Atavi System Summary page 2 …May 12, 2006 5.5 Predicate Devices Device Name(s): Endius Atavi System 510(k) Number(s): K991794, K994425, K002437, K021748, K022199, K053267 5.6 Device Description The Endius Atavi System includes instruments used to access the spine by dilation of the overly…	Endius, Inc.	2002	—
*	K053267	Endius Atavi System Summary page 2 …May 12, 2006 5.5 Predicate Devices Device Name(s): Endius Atavi System 510(k) Number(s): K991794, K994425, K002437, K021748, K022199, K053267 5.6 Device Description The Endius Atavi System includes instruments used to access the spine by dilation of the overlying tissu…	Endius, Inc.	2006	1

Also cleared against K991794: 3 other devices →

What descends from it? (17)

See all 17

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K081051	Spinevu Endoscopic Spine System (Sess), Spinevu Miniscope	Spine View, Inc.	2008	16
K113362	Spinevu Endoscopic Spine System (Sess)	Spine View, Inc.	2012	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 8, 2013	Class II	Z-1045-2013	Package design/selection	Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a sterile inner pouch within an external pouch. NexPosure Retractors contained in a breached inner pouch have an increased risk of contamination…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 2.9 years on median.
1 of the 7 ancestors has a recall of any class.
Of its descendants, K081051 (Spine View, Inc., 2008) has gone furthest, with 16 descendants of its own.
3 other devices also cite its predicate K991794.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRX

9in 2025

2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007high 249 (2023) · low 45 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRX

1in 2024

2007high 23 (2009) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRX

2,076in 2025

2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	7	89	3	421
2008	9	115	13	441
2009	11	139	23	558
2010	9	114	12	612
2011	3	84	6	631
2012	11	102	0	778
2013	12	90	4	678
2014	9	140	0	802
2015	4	132	7	763
2016	8	89	0	469
2017	4	97	0	934
2018	12	101	1	1,581
2019	12	45	0	1,676
2020	7	141	0	1,706
2021	7	57	3	1,908
2022	3	89	0	1,406
2023	4	249	0	1,852
2024	6	110	1	2,427
2025	9	107	0	2,076
2026	7	217	0	—

What is it indicated for?

The Endius Atavi System is indicated for use for posterior or anterior access and visualization in the surgical area of cervical, thoracic, or lumbar spine allowing the surgeon to perform any type of surgical spinal procedures such as discectomy, nucleotomy, spinal fusion, spinal decompression, and insertion of spinal implants. Other examples of generic surgical use of the Endius Atavi system would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061345 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061345: Modification to Endius Atavi System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061345

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026